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January 10, 2026
Approximately 5 minutes
Medical Device Regulation in Brazil: ANVISA Risk Classification, Registration, and Certification Requirements
Medical Device Regulation in Brazil: ANVISA Risk Classification, Registration, and Certification Requirements
1. Definition and Scope
Medical devices in Brazil are defined as instruments, apparatus, equipment, implants, in vitro diagnostics, software, materials, or articles intended for medical purposes such as diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury, without primary pharmacological, immunological, or metabolic action. ANVISA oversees all stages of the device lifecycle, including imports. Source: ANVISA - Medical Devices Regulation (https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices)
2. Risk Classification (Classes I to IV)
Devices are classified into four risk classes based on intended purpose and risk level:
- Class I: Low risk
- Class II: Moderate risk
- Class III: High risk
- Class IV: Maximum risk
Rules are detailed in RDC No. 751/2022 for general devices and RDC No. 830/2023 for IVDs. Software as a medical device (SaMD) follows Rule 12 in RDC No. 751/2022. Source: ANVISA - Medical Devices Regulation (https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices)
3. Registration Pathways
Notification (Classes I and II)
Lower-risk devices require notification with abridged documentation. Authorization is indefinite but may be cancelled for irregularities. Source: ANVISA - Medical Devices Regulation (https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices)
Registration (Classes III and IV)
Higher-risk devices require full dossier review, including performance evaluation (for certain IVDs), labeling, GMP certification, and other documents. Valid for 10 years, renewable. Special rules apply to orthopedic implants under RDC No. 925/2024. Source: ANVISA - Medical Devices Regulation (https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices)
4. Certification and GMP Requirements
- Good Manufacturing Practices (GMP): Mandatory for manufacturers of Class III and IV devices. A valid GMP certificate is required for registration. Source: ANVISA - Medical Devices Regulation (https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices)
- Brazilian Conformity Assessment (SBAC): Required for electromedical equipment under RDC No. 549/2021, involving certification by INMETRO-accredited bodies. Essential safety and performance requirements are outlined in RDC No. 848/2024. Source: ANVISA - Medical Devices Regulation (https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices)
5. Requirements for Imported Devices
Foreign manufacturers must appoint a Brazilian holder responsible for registration and distribution. Reliance on Equivalent Foreign Regulatory Authorities (AREE) may streamline assessment if product sameness is proven. Import of used or refurbished implantable devices is generally prohibited; non-implantables may be allowed under specific conditions (RDC No. 579/2021). Source: ANVISA - Medical Devices Regulation (https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices)
6. Specific Rules for IVDs and SaMD
IVDs follow RDC No. 830/2023. High-risk IVDs require performance evaluation, sometimes by official labs. SaMD is regulated under RDC No. 657/2022, with specific labeling and instructions. UDI requirements are in RDC No. 591/2021. Source: ANVISA - Medical Devices Regulation (https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices)
7. Clinical Data and Post-Market Obligations
Clinical data are mandatory for Class III/IV devices, often via literature or investigations compliant with ISO 14155:2020. Post-market, authorizations may be cancelled for non-compliance; renewals involve re-evaluation. Source: ANVISA - Medical Devices Regulation (https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices)
8. Key Resources and Recent Updates
Key resolutions include RDC No. 751/2022 (general framework), RDC No. 830/2023 (IVDs), RDC No. 848/2024 (safety requirements), and others. Grouping of similar products is allowed under Normative Instruction No. 320/2024. Page updated as of September 2025. Source: ANVISA - Medical Devices Regulation (https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices)
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